THE CUPIDO STUDY: The effect of the multispecies probiotic Ecologic 825 versus placebo in Ulcerative Colitis patients

Completed

Conditions: inflammatory bowel disease (IBD)
Ulcerative Colitis (CU)
10017969

Registration Number: NL-OMON40262

Lead Sponsor: Wageningen Universiteit

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

- Diagnosed Ulcerative Colitis (left sided UC or pancolitis)
- Age 18-65 (because microbiotia change at older age)
- Stable disease activity (clinical remission with CRP levels <10mg/L) as measured at baseline
- Mesalazine medication as only medication for UC with a maximum intake of 2.4 g/day

Exclusion Criteria

- History of intestinal surgery that might interfere with the outcome of the study
- Diabetes Mellitus (medication dependent)
- Current use of antibiotics
- Current use of corticosteroids (30 days prior to the first baseline measurement).
- Treatment with other medication besides mesalazine (NSAIDs, topical or systemic steroids, immunosuppressive drugs or aspirin) one week prior the first baseline measurement.
- Use of other pre- and probiotics and not willing to stop these 2 weeks before the intervention period
- Hypersensitivity or allergy to milk protein, soy protein and gluten
- Alcohol abuse (male more than 14 servings a week, female more than 7 servings a week)
- Female patients: currently pregnant or breast-feeding or intending to become pregnant during the study
- Patients foreseen to need GI surgery during the study period
- Patients with a history of cancer

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameter is intestinal permeability measured by several<br /><br>techniques: the Multi Sugar Absorption test in 24-h urine, zonulin in faeces<br /><br>and in serum. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Inflammation will be measured from faecal calprotectin and blood c-reactive<br /><br>protein (CRP) levels. Furthermore samples will be stored to measure cytokine<br /><br>concentrations in serum and to analyse the microbial composition of the faecal<br /><br>samples using the HITchip. For the disease related quality of life the<br /><br>irritable bowel disease questionnaire (IBD-Q) and SF-36 will be used. All<br /><br>parameters will be measured at three time points; t=0, t=6 and t=12 weeks. </p><br>